WHO prequalification is a programme which aims to ensure that key health products meet stringent global standards of quality, safety and efficacy.
It is managed by WHO and aims to optimize use of health resources and improve health outcomes by ensuring assessed products meet stringent quality standards for international procurement, such as for the United Nations. It is the only global medicines quality assurance programme and conducts transparent and scientifically sound assessments for immunization devices, in vitro diagnostics, medicines, vaccines and vector control products.
Assessments for WHO prequalification may include:
- dossier review
- product testing
- inspection of manufacturing and testing sites
- quality control testing
- verifying that the products are suitable for use in the destination countries
A team of inspectors verifies compliance of manufacturers with international standards for product prequalification. They collaborate with product teams to prioritize inspections and ensure all requirements are met before approval. The prequalification outputs include lists of prequalified products, the list of prequalified quality control laboratories, and WHO Public Assessment and Inspection Reports.